BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN

    MDR report key: 3844027 · Received June 2, 2014

    Report

    Report Number
    2015691-2014-01277
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE 111F7 CATHETER WITHOUT THE INTRODUCER BEING USED FOR EXAMINATION. EXAMINATION OF THE CATHETER FOUND THE CATHETER BODY TO BE UNDAMAGED. THE LENGTH OF THE CATHETER WAS MEASURED AND THERE WAS NO STRETCH OBSERVED. THE CATHETER OD WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE BALLOON LATEX WAS RECEIVED BAGGY ALTHOUGH DOES INFLATE CLEAR AND CONCENTRIC AND REMAINED INFLATED WITHOUT LEAKAGE. THE BAGGY BALLOON MAY BE DUE TO OVER INFLATION OR PROLONGED INFLATION MAKING THE LATEX BAGGY. THE CATHETER WAS PASSED THROUGH AN EDWARDS INTROFLEX 7F TOUHY BORST TYPE INTRODUCER, AND THE CATHETER PASSED FREELY THE ENTIRE LENGTH. IN ADDITION, THE DISTAL LUMEN WAS FOUND TO BE PATENT AND DID NOT LEAK. IT IS UNKNOWN IF SOME OTHER PROCEDURAL FACTORS MAY HAVE OCCURRED WHICH COULD NOT BE DUPLICATED IN OUR LABORATORY SETTING. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER COULD NOT BE REMOVED FROM THE CORTIS 7F SHEATH WHILE TORQUING ON ROTATOR CUFF. THE CATHETER WAS REMOVED BUT APPEARED TO BE STRETCHED. A SECOND CATHETER WAS USED, REQUIRING A NEW INSERTION SITE, AND AGAIN IT WAS DIFFICULT TO EXTRACT THE CATHETER FROM THE SHEATH RESULTING IN THE CATHETER BEING STRETCHED. A THIRD CATHETER WAS USED AND WORKED FINE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322128 SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO EDWARDS LIFESCIENCES PR 111F7 59691971

    Patients

    Seq Age Sex Outcome Treatment
    1